Device Classification Name |
instrument, biopsy
|
510(k) Number |
K040842 |
Device Name |
SENORX BIOPSY DEVICE II |
Applicant |
SENORX, INC. |
11 COLUMBIA, SUITE A |
ALISO VIEJO,
CA
92656
|
|
Applicant Contact |
AMY BOUCLY |
Correspondent |
SENORX, INC. |
11 COLUMBIA, SUITE A |
ALISO VIEJO,
CA
92656
|
|
Correspondent Contact |
AMY BOUCLY |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 04/01/2004 |
Decision Date | 04/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|